Smart Coil 400SMTSTD1545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548014296), received between Jun 11, 2018 and Sep 11, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE INITIAL POSITION. THE SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER SMART COIL. HOWEVER, THE SAME ISSUE OCCURRED, AND THE SECOND SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED FOUR SMART COILS INDIVIDUALLY TO THE TARGET VESSEL. THE HANDLE TOOK TWO TO THREE ATTEMPTS TO DETACH THE FIRST, SECOND, AND THIRD SMART COILS, AND THE HANDLE WAS UNABLE TO DETACH THE FOURTH SMART COIL. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE FOURTH SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND ANOTHER HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522702 ↗
• MalfunctionNov 21, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY (ECA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE SMART COIL. THE PHYSICIAN THEN CHOSE ANOTHER SMART COIL AND WAS ABLE TO ADVANCE IT A LITTLE FARTHER THAN THE PREVIOUS SMART COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND UPON REMOVAL, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097959 ↗
• MalfunctionJun 11, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL IN A NON-PENUMBRA MICROCATHETER, THE SMART COIL PUSHER ASSEMBLY BECAME KINKED AT THE POINT OF THE JUNCTION WITH THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7587552 ↗